Expanded Access Program
Expanded Access Program
We Go Where Society Has a Need
Known as ‘Compassionate Use’, the FDA allows patients to have access to some treatments outside of Phase 3 trials.
Qualifications for Expanded Access Program:
- Patient has a serious/immediately threatening disease or condition.
- There is no comparable or satisfactory alternative therapy.
- Patient enrollment in a clinical trial is not possible.
- Potential benefits justify any potential risks of treatment.
- Providing the investigational medical product will not interfere with clinical trials.
Our Application for Expanded Access was Submitted to the FDA in January 2019.
The primary intent is to provide MDMA-assisted therapy for PTSD, rather than to collect efficacy data.
If approved by the FDA, the program will start in 2019 at a limited number of sites. FDA regulations enable manufacturers of investigational treatments to provide patients access to the drug under certain situations if they cannot participate in a clinical trial.
Expanded Access is not the same as The Right to Try. Since MDMA is not given as a take home medication, the right to try is likely not to become an option. If MDMA-assisted therapy is approved for Expanded Access, availability of treatment is limited and not guaranteed to patients who qualify.